Febrile Illness in Kinshasa and Kimpese (FIKI²)

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Febrile Illness

Treatments: Other: Observational study

Study type: Observational

Funder types: Other

Identifiers

NCT04760678

FIKI²

Details and patient eligibility

About

This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the DRC. The study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures.

Each patient will be followed for 21 days. The follow-up will include

• Daily visits for hospitalized patients,
• Telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients.

The study has been amended (EC UZA approval in June 2021) to perform a set of laboratory analyses in the partners institutions and at the ITM. We aim as a new primary objective at describing the profile of different biomarkers (C-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). The purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.

Enrollment: 1,046 patients

Sex: All

Ages: 2+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:

   • Axillary or tympanic temperature > 37.5°C OR
   • Oral or rectal temperature > 38°C

2. Possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21

3. Informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible.

Exclusion criteria

1. Children less than two months old
2. Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)

Trial design